ISO/TS 11633-1:2019 健康情報学—医療機器と医療情報システムのリモートメンテナンスのための情報セキュリティ管理—パート1：要件とリスク分析 | ページ 2

Foreword

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This document was prepared by Technical Committee ISO/TC 215, Health informatics.

This first edition cancels and replaces ISO/TR 11633-1:2009, which has been technically revised. The main changes compared to the previous edition are as follows:

• complete revision to correspond to the latest editions of the reference standards, ISO/IEC 27001 and ISO/IEC 27002;
• addition of use case 'remote monitoring'.

A list of all parts in the ISO 11633 series can be found on the ISO website.

Introduction

The advancement and spread of technology in the information and communication technology field, and the infrastructure based on them, have brought many changes in how technology and networks are used in modern society. Similarly, in healthcare, information systems which were once closed in each healthcare facility (HCF) are now connected to the outside by networks and are progressing to the point of being able to facilitate mutual use of health information accumulated in these information systems. Such information and communication networks are spreading not only in between HCFs but also between HCFs and vendors of medical devices and healthcare information systems. Maintenance of such systems is paramount to keeping them up-to-date. By practicing so-called 'remote maintenance services', it becomes possible to reduce down-time and lower costs for this maintenance activity.

Whilst there are benefits to remote maintenance, such remote connections with external organizations also expose HCFs and vendors to risks regarding confidentiality, integrity and availability of information and systems; risks which previously received scant consideration.

Although normal remote maintenance is generally done on a contract basis, in the case of medical devices, risk assessment is commonly a legal prerequisite. Therefore, it is necessary to implement appropriate risk assessment where remote maintenance is provided in any healthcare context. The risk assessment examples provided in ISO/TR 11633-2 provide support for HCFs and RMS providers to implement risk assessment effectively.

By implementing the risk assessment process and employing controls referencing ISO/TR 11633-2, HCFs owners and RMS providers will be able to obtain the following benefits:

• Risk assessment can result in improved efficiency. If the risk assessment document created through the use of ISO/TR 11633-2 does not fully conform to ISO/IEC 27001, it can be used in part in a risk assessment of an incompatible area, thus reducing the risk assessment effort required.
• Documented validity of the RMS security countermeasures in place will be available to third parties.

If providing RMS to two or more sites, the provider can apply countermeasures consistently and effectively.

1 Scope

This document focuses on remote maintenance services (RMS) for information systems in healthcare facilities (HCFs) as provided by vendors of medical devices and health information systems.

This document specifies the risk assessment necessary to protect remote maintenance activities, taking into consideration the special characteristics of the healthcare field such as patient safety, regulations and privacy protections.

This document provides practical examples of risk analysis to protect both the HCF and RMS provider information assets in a safe and efficient (i.e. economical) manner. These assets are primarily the information system itself and personal health data held in the information system.

2 Normative references

There are no normative references in this document.

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

Bibliography